POS0278 EFFICACY AND SAFETY OF SECUKINUMAB IN JUVENILE IDIOPATHIC ARTHRITIS: INTERIM RESULTS FROM THE EXTENSION OF THE JUNIPERA TRIAL
Authors: N. Ruperto, I. Foeldvari, E. Alexeeva, N. Aktay Ayaz, G. Schulert, S. Özen, A. Popov, A. Ramanan, C. Scott, B. Sozeri, E. Zholobova, S. Chakraborty, X. Zhu, R. Martin, S. Whelan, S. Kaur, L. Pricop, D. J. Lovell, A. Martini, H. Brunner
Journal: Annals of the Rheumatic Diseases (2023)

<h3>Background</h3> Secukinumab has demonstrated efficacy and safety in patients with enthesitis-related arthritis (ERA) and juvenile psoriatic arthritis (JPsA) categories of juvenile idiopathic arthritis (JIA) for up to 2 years.<sup>[1]</sup> After completion of a 2-year core study (JUNIPERA), a long-term extension (LTE) study was conducted to evaluate the continued efficacy and safety of secukinumab. <h3>Objectives</h3> To report interim efficacy and safety results of the LTE study of secukinumab in patients with ERA and JPsA. <h3>Methods</h3> In the core study, a total of 86 patients (2 to &lt;18 years of age) received secukinumab up to week 12 in the open-label (OL) period.<sup>[1]</sup> JIA ACR30 responders at week 12 (n=75) were subsequently randomised to secukinumab (n=37) or placebo (n=38) up to week 100 in study period 2. Those who flared after randomisation (secukinumab, n=10; placebo, n=21) received OL secukinumab up to week 100.<sup>[1]</sup> A total of 54 out of 61 patients who had completed the core study consented to enter the LTE study and received secukinumab (s.c.) (75/150 mg in patients &lt;50/ ≥50 kg) every 4 weeks up to 4 years. Patients whose signs and symptoms were not fully controlled, as judged by the investigator in the LTE, could have dose escalation of their secukinumab dose from 75 mg to 150 mg or 150 mg to 300 mg. Median Juvenile Arthritis Disease Activity Scores (JADAS)-27 were presented up to week 156 for efficacy, and adverse events (AEs) and serious AEs were presented for the entire treatment period up to the cut-off date (maximum up to week 232). <h3>Results</h3> JADAS-27 in the core study and in the LTE are presented in the <b>Figure 1</b>. A total of 19 patients had dose escalation in the LTE: 8 patients from 75 mg to 150 mg and 11 patients from 150 mg to 300 mg. The overall exposure-adjusted incidence rate per 100 patient-years (PY) of treatment-emergent AEs was 98.4 PY in the entire JIA population. The most commonly reported AEs (preferred term, safety set 5% cut off) were nasopharyngitis (n=9, 16.7%) and arthralgia (n=8, 14.8%). One major adverse cardiovascular event, not related to the study drug, and 2 cases of uveitis were reported. No cases of Crohn's disease or deaths were reported, and no patient discontinued treatment due to an AE. <h3>Conclusion</h3> With secukinumab treatment, the JADAS-27 inactive disease status was sustained from week 104 to week 156 in patients with JIA who had completed the 2-year core study and enrolled in the LTE study. Safety data were consistent with adult and paediatric indications, with no new or unexpected safety signals. <h3>Reference</h3> [1]Brunner HI, et al. <i>Ann Rheum Dis</i>. 2023;82(1):154-160. <h3>Acknowledgements</h3> The trial was designed jointly by the PRINTO and PRCSG study groups, and Novartis Pharma AG. <h3>Disclosure of Interests</h3> Nicolino Ruperto Speakers bureau: Ablynx, AstraZeneca-Medimmune, Bayer, Biogen, Boehringer, Bristol Myers and Squibb, Celgene, Eli-Lilly, EMD Serono, Glaxo Smith and Kline, Hoffmann-La Roche, Janssen, Merck, Novartis, Pfizer, R-Pharma, Sinergie, Sobi and UCB, Consultant of: Ablynx, AstraZeneca-Medimmune, Bayer, Biogen, Boehringer, Bristol Myers and Squibb, Celgene, Eli-Lilly, EMD Serono, Glaxo Smith and Kline, Hoffmann-La Roche, Janssen, Merck, Novartis, Pfizer, R-Pharma, Sinergie, Sobi and UCB, Grant/research support from: BMS, Eli-Lilly, GlaxoSmithKline, F Hoffmann-La Roche, Janssen, Novartis, Pfizer, Sobi, Ivan Foeldvari Consultant of: Novartis, BMF, Bayer, Genentech, Sanofi, Abbvie, Chugai, Medac, BMS, Pfizer, Ekaterina Alexeeva Speakers bureau: Novartis, Pfizer, Sanofi, MSD, Amgen, Eli Lilly, Roche, Grant/research support from: Novartis, Pfizer, Sanofi, MSD, Amgen, Eli Lilly, Roche, NURAY AKTAY AYAZ: None declared, Grant Schulert Consultant of: Novartis, Grant/research support from: Novartis, Seza Özen: None declared, Artem Popov: None declared, Athimalaipet Ramanan Speakers bureau: Roche, Sobi, Eli Lilly, UCB, Novartis, Christiaan Scott: None declared, Betul Sozeri: None declared, Elena Zholobova Speakers bureau: Abbvie, Pfizer, Roche, Novartis, Grant/research support from: Pfizer, Novartis, Sudhanshu Chakraborty Shareholder of: IQVIA, Employee of: IQVIA, Xuan Zhu Shareholder of: Novartis, Employee of: Novartis, Ruvie Martin Shareholder of: Novartis, Employee of: Novartis, sarah whelan Shareholder of: Novartis, Employee of: Novartis, Sharonjeet Kaur Shareholder of: Novartis, Employee of: Novartis, Luminita Pricop Shareholder of: Novartis, Employee of: Novartis, Daniel J Lovell Speakers bureau: Abbott, Novartis, Consultant of: AstraZeneca, Wyeth, Amgen, Abbott, Pfizer, Hoffmann-La Roche, Novartis, UBC, Janssen, GlaxoSmithKline, Boehringer Ingelheim, Celgene, Bristol Myers Squibb, AbbVie, Alberto Martini Speakers bureau: Eli Lilly, EMD Serono, Janssen, Novartis, Pfizer, Abbvie, Consultant of: Eli Lilly, EMD Serono, Janssen, Novartis, Pfizer, Abbvie, Hermine Brunner Speakers bureau: Pfizer, Roche and GlaxoSmithKline, Consultant of: Aurinia, Abbvie, AstraZeneca-Medimmune, Biogen, Boehringer, Bristol-Myers Squibb, Celgene, Eli Lilly, EMD Serono, GlaxoSmithKline, F. Hoffmann-La Roche, Merck, Novartis, R-Pharm, Sanofi, Pfizer, Grant/research support from: Bristol-Myers Squibb, Eli Lilly, GlaxoSmithKline, F. Hoffmann-La Roche, Janssen, Novartis, and Pfizer.